Health Condition 1: K77- Liver disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Saroglitazar: Tab. Saroglitazar 4mg Once a day for 6 months
Control Intervention1: Placebo: Placebo once daily for 6 months
Sponsors
No sponsor
Eligibility
Inclusion criteria
Inclusion criteria: i) Age -18-60 years ii) Either of the gender (Male and female) iii)Evidence of fatty liver on USG iv) Patient’s willingness to comply with the study protocol and prior written informed consent
Exclusion criteria
Exclusion criteria: 1)Alcoholics for past 6 months 2)Patients with type i or type 2 diabetes mellitus 3) Patients with alternate causes of fatty liver including: -Patients on TPN and those who underwent surgical procedures within 90 days from randomization -presence of other chronic liver disease such as hepatitis B or C, liver cirrhosis, Wilson’s disease or any other autoimmune condition leading to fatty liver 4) Use of drugs with potential effect on NASH such as: Ursodeoxycholic acid, SAdenosyl Methionine(SAM-e), Betaine, Pentoxyfylline, Obeticholic acid, milk thistle, Vitamin E, statins, CYP3C8 inhibitors or substrate -within 3 months before visit 1 5) Presence of bleeding disorders, myopathy, malignancy, hypothyroidism 6) Presence of anaemia, acute or chronic kidney disease, acute or chronic liver disease 7) Participation in other NAFLD/NASH related study within last 3 months 8) Pregnant or lactating females or couples planning pregnancy within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in CAP values on FibroscanTimepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in BMI, body weight, Waist-Hip ratioTimepoint: 24 weeks;Mean change from baseline in FBS, HbA1c, HOMA-IRTimepoint: 24 weeks;Mean change from baseline in lipid profileTimepoint: 24 weeks;Mean change from baseline in serum alanine amino transferase valuesTimepoint: 24 weeks;Mean change in FIB-4 scoreTimepoint: 24 weeks;Mean change in Hepatic steatosis indexTimepoint: 24 weeks;Mean change in LSM values from baselineTimepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr Divya Harsha
All India Institute of Medical Sciences
Outcome results
None listed